A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondr… (NCT01310816) | Clinical Trial Compass
CompletedPhase 2
A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
United States105 participantsStarted 2011-02
Plain-language summary
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age at the time of signing informed consent.
* Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
* Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
* At least 1 radiologically measurable target lesion per RECIST 1.1.
* Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
* Life expectancy of at least 3 months
* All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug.
* Ability to adhere to the study visit schedule and all protocol requirements.
* Voluntarily signed an informed consent form.
Exclusion Criteria:
* Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
* Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
* Prior treatment with a Hedgehog pathway inhibitor
* Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
* Inadequ…